Veterans Administration, Tennessee Valley Healthcare System, Tennessee Valley Geriatric Research Education Clinical Center (GRECC), Nashville, TN 37212, USA.
Pharmacoepidemiol Drug Saf. 2009 Nov;18(11):1053-63. doi: 10.1002/pds.1820.
To determine if certain non-steroidal anti-inflammatory drugs (NSAIDs) are associated with increased risk of cardiovascular events: acute myocardial infarction (AMI), stroke, and death from coronary heart disease (CHD).
We conducted a retrospective cohort study of Tennessee Medicaid enrollees aged 35-94 years between 1 January 1999 and 31 December 2005. Eligible persons were non-institutionalized, had continuous enrollment, and had no serious illness prior to cohort entry. Exposure to celecoxib, rofecoxib, valdecoxib, ibuprofen, naproxen, diclofenac, and indomethacin was studied. The outcome was hospitalization for AMI, stroke, or death from CHD among those with and without a history of cardiovascular disease (CVD). Adjusted hazard ratios (aHR) and 95% confidence intervals (95% CI) are reported.
There were 610 001 persons in the final cohort and 14% had a baseline history of CVD. In those without CVD (N = 525 249) there were 1 566 678 person-years of follow-up and 12 184 events. In this group, non-users had 7.90 events/1000 person-years. Events/1000 person-years were 10.41 for current use of celecoxib (aHR 1.00, 95% CI 0.89-1.13), 10.91 for rofecoxib (aHR 1.21, 95% CI 1.07-1.37), 12.46 for valdecoxib (aHR 1.30 95% CI 1.04-1.61), and 13.25 for indomethacin (aHR 1.36, 95% CI 1.11-1.66) compared to non-users. Among patients with a past history of CVD (N = 84 752) there were 397 977 person-years of follow-up and 10 248 events. Non-users had 28.30 events/1000 person-years. Among those with CVD, rofecoxib use was associated with increased event rate (30.28 events/1000 person-years [aHR 1.21, 95% CI 1.08-1.37]) and naproxen was associated with a decreased event rate (22.66 events/1000 person-years [aHR 0.88, 95% CI 0.79-0.99]). Among new users, the results were similar except risk among naproxen users was no longer different than non-users.
We found an increased risk of cardiovascular events among all and new current users of rofecoxib, valdecoxib, and indomethacin in patients with no history of CVD. Among patients with CVD, all and new current rofecoxib use was associated with an increased risk of a cardiovascular event.
确定某些非甾体抗炎药（NSAIDs）是否与心血管事件（急性心肌梗死 [AMI]、中风和冠心病 [CHD] 死亡）风险增加有关。
我们对 1999 年 1 月 1 日至 2005 年 12 月 31 日期间田纳西州医疗补助计划的 35-94 岁非住院患者进行了回顾性队列研究。合格人员为非机构化，连续参保，且在队列入组前无严重疾病。研究了塞来昔布、罗非昔布、伐地昔布、布洛芬、萘普生、双氯芬酸和吲哚美辛的暴露情况。研究了有无心血管疾病（CVD）病史的患者中因 AMI、中风或 CHD 死亡而住院的情况。报告了调整后的危险比（aHR）和 95%置信区间（95%CI）。
最终队列中有 610011 人，其中 14%有基线 CVD 病史。在无 CVD 的患者（N=525249）中，有 1566678 人年的随访和 12184 例事件。在该组中，非使用者的事件发生率为每 1000 人年 7.90 例。每 1000 人年的事件发生率为：当前使用塞来昔布者为 10.41（aHR 1.00，95%CI 0.89-1.13），当前使用罗非昔布者为 10.91（aHR 1.21，95%CI 1.07-1.37），当前使用伐地昔布者为 12.46（aHR 1.30，95%CI 1.04-1.61），当前使用吲哚美辛者为 13.25（aHR 1.36，95%CI 1.11-1.66），与非使用者相比。在有 CVD 病史的患者（N=84752）中，有 397977 人年的随访和 10248 例事件。非使用者的事件发生率为每 1000 人年 28.30 例。在 CVD 患者中，罗非昔布的使用与更高的事件发生率相关（每 1000 人年 30.28 例[aHR 1.21，95%CI 1.08-1.37]），而萘普生与更低的事件发生率相关（每 1000 人年 22.66 例[aHR 0.88，95%CI 0.79-0.99]）。在新使用者中，结果相似，但萘普生使用者的风险不再与非使用者不同。
我们发现，在无 CVD 病史的患者中，所有新的当前使用罗非昔布、伐地昔布和吲哚美辛的患者心血管事件风险均增加。在有 CVD 的患者中，所有新的当前使用罗非昔布与心血管事件风险增加有关。
